氯吡格雷阿司匹林片制备及体外溶出一致性评价  

Preparation and in vitro dissolution consistency of clopidogrel and aspirin tablets

作　　者：钱方 伍贤志 QIAN Fang;WU Xian-zhi(College of Pharmacy,Anhui University of Chinese Medicine,Hefei 230012;Yangtze Delta Drug Advanced Research Institute,Nantong Jiangsu 226133;Jiangsu Wangao Pharmaceutical Co.,Ltd.,Nantong Jiangsu 226100)

机构地区：[1]安徽中医药大学药学院,合肥230012 [2]长三角药物高等研究院,江苏南通226133 [3]江苏万高药业股份有限公司,江苏南通226100

出　　处：《中南药学》2024年第6期1498-1504,共7页Central South Pharmacy

摘　　要：目的 制备氯吡格雷阿司匹林片,并对其处方工艺进行优化,以实现与参比制剂体外溶出行为一致。方法 氯吡格雷采用热熔制粒制备工艺,阿司匹林采用粉末直压、肠溶包衣制备工艺。单因素考察制备过程的关键处方工艺因素,以获得最优的处方工艺条件。通过高效液相色谱法对氯吡格雷和阿司匹林的溶出度进行测定,采用相似因子f_(2)法比较自制制剂与参比制剂的溶出曲线。结果 经过优化的自制制剂与参比制剂在不同介质中的f_(2)均大于50,溶出曲线相似。结论 氯吡格雷阿司匹林片自制制剂与参比制剂体外溶出行为一致。Objective To prepare clopidogrel and aspirin tablets and optimize the formulation process to achieve consistency with the reference preparation on dissolution behavior in vitro.Methods Clopidogrel was prepared by hot melt granulation and aspirin was prepared by direct powder compression method and enteric coating.The key formulation factors of the preparation process were determined by single factor to obtain the optimal formulation conditions.The dissolution of clopidogrel and aspirin was determined by high performance liquid chromatography.The dissolution curves of self-made preparation and reference preparation were compared by similarity factor f_(2) method.Results The f_(2) of the optimized self-made preparation and the reference preparation in different media was greater than 50,with similar dissolution curves.Conclusion The dissolution behavior of self-made clopidogrel and aspirin tablets in vitro is consistent with that of reference preparation.

关 键 词：氯吡格雷 阿司匹林 体外溶出 热熔制粒 相似因子 

分 类 号：R945[医药卫生—微生物与生化药学]